Trial Title:
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
NCT ID:
NCT05638269
Condition:
Essential Hypertension
Liver Cancer
Nasopharyngeal Cancer
Pancreatic Cancer
Lung Cancer
Chronic Kidney Diseases
Acute Coronary Syndrome
Epilepsy
Gastric Cancer
Primary Aldosteronism
Subclinical hypothyroïdism
Conditions: Official terms:
Nasopharyngeal Neoplasms
Nasopharyngeal Carcinoma
Kidney Diseases
Renal Insufficiency, Chronic
Acute Coronary Syndrome
Essential Hypertension
Hypothyroidism
Hyperaldosteronism
Chronic Disease
Conditions: Keywords:
cardiovascular disease
exctracoonic cancer
nervous system diseases
endocrine diseases
urological diseases
microbial dysbiosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
no intervention
Description:
Observational studies, no intervention
Arm group label:
control group
Arm group label:
disease group
Summary:
The human gut microbiome has been associated with many health factors but variability
between studies limits the exploration of effects between them. This study aims to
systematically characterize the gut microbiota of various critical chronic diseases,
compare the similarities and differences of the microbiome signatures linked to different
regions and diseases, and further investigate their impacts on microbiota-based
diagnostic models.
Detailed description:
Many studies demonstrate that microbial dysbiosis has been linked to many human
pathologies. However, the current understanding of the identification of the
disease-associated microbiome signatures remains limited, largely owing to the
heterogeneity of microbial community structures which are shaped by the host.
Undoubtedly, profiles of microbial biomarkers require validation in large, independent,
population-based cohorts from different districts. Based on these, the investigator plan
to organize a multicentric cross-sectional cohort, not only to systematically
characterize the gut microbiota of various critical chronic diseases, such as liver
cancer, gastric cancer, pancreatic cancer, lung cancer, nasopharyngeal cancer,
hypertension, acute coronary syndrome, primary aldosteronism, epilepsy, chronic kidney
disease, and subclinical hypothyroidism but also to compare the similarities and
differences of the microbiome signatures linked to different regions and different
diseases and to further investigate their impacts on microbiota-based diagnostic models.
In this study, for each kind of disease, the investigators expect to recruit 500 patients
with a confirmed diagnosis and 500 sex- and age-matched controls, to record their
information related to demography, body measurement, lifestyle, diet, medication,
diseases, and biochemistry, and to collect their feces, saliva, urine and blood samples.
Criteria for eligibility:
Study pop:
All the patients with essential Hypertension, liver cancer, nasopharyngeal cancer,
pancreatic cancer, lung cancer, chronic kidney disease, acute coronary syndrome,
epilepsy, gastric cancer, primary aldosteronism or subclinical hypothyroidism
hospitalized in our participant hospitals will be eligible to be enrolled. Also, their
age- and sex-matched controls making a physical examination in the same hospital will be
eligible to be enrolled.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. aged 18-75 years;
2. living in the province where the hospital is located in the last three years;
3. with a medical diagnosis of one of the target diseases;
4. willing to provide written informed consent.
Exclusion Criteria:
1. female in pregnancy or lactation(unless the subject is pregnant women);
2. with medical diagnoses of other serious illnesses;
3. with a history of bariatric surgery or intestinal resection, except for
appendectomy；
4. individual who was treated with drugs in the preceding 1 month, including
antibiotics, metformin, statins, acid inhibitor, probiotics, and probiotics;
individuals having consumed yogurt more than 3 times in the preceding 1 month; heavy
drinkers who have consumed more than 4 taels of liquor or 1000ml of beer; frequent
alcohol consumers who have drunk per week in the last month.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Emergency General Hospital
Address:
City:
Chaoyang
Zip:
100028
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hui Xu
Phone:
13693568626
Facility:
Name:
The People's Hospital Of Nanchuan Chongqing
Address:
City:
Nanchuan
Zip:
408400
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenming Wang
Phone:
13996856392
Facility:
Name:
YongChuan hospital of Chongqing Medical Univeristy
Address:
City:
Yongchuan
Zip:
402177
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoli Zhang
Phone:
13504549189
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Yingping Cao
Phone:
13365910806
Facility:
Name:
Fujian Provincial Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Falin Chen
Phone:
13600807079
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Chen
Phone:
13905010494
Facility:
Name:
The First Hospital of Lanzhou University
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liqiong Yao
Phone:
13919300448
Facility:
Name:
Lanzhou University Second Hospital
Address:
City:
Lanzhou
Zip:
730030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Gechong Yong
Phone:
13919309189
Facility:
Name:
The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )
Address:
City:
Foshan
Zip:
528200
Country:
China
Status:
Recruiting
Contact:
Last name:
Tian Cai
Phone:
13106598603
Facility:
Name:
The First Affiliated Hospital of Jinan University（Guangzhou Overseas Chinese Hospital ）
Address:
City:
Guangzhou
Zip:
510600
Country:
China
Status:
Recruiting
Contact:
Last name:
Minmin Li
Phone:
18903078510
Facility:
Name:
The seventh Affiliated Hospital, Sun Yat-sen University
Address:
City:
Shenzhen
Zip:
518107
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhaofan Luo
Phone:
18002295130
Facility:
Name:
Zhongshan City People's Hospital
Address:
City:
Zhongshan
Zip:
564000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kang Chen
Phone:
18898389835
Facility:
Name:
The Second Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530007
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li Xie
Phone:
13737089977
Facility:
Name:
People's Hospital of Guangxi Zhuang Autonomous Region
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yulin Yuan
Phone:
13878813926
Facility:
Name:
Wuzhou Red Cross Hospital
Address:
City:
Tongliao
Zip:
543002
Country:
China
Status:
Recruiting
Contact:
Last name:
Minzhong Tang
Phone:
13481411516
Facility:
Name:
The Affiliated Cancer Hospital of Guizhou Medical University
Address:
City:
Guiyang
Zip:
550001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wei Wang
Phone:
18786126238
Facility:
Name:
The Affiliated Hospital of Guizhou Medical University
Address:
City:
Guiyang
Zip:
550004
Country:
China
Status:
Recruiting
Contact:
Last name:
Hai Huang
Phone:
18985111828
Facility:
Name:
Hainan Traditional Chinese Medicine Hospital
Address:
City:
Haikou
Zip:
570100
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiang Wu
Phone:
13337600255
Facility:
Name:
Daqing People's Hospital（The Fifth Affiliated Hospital of Harbin Medical University）
Address:
City:
Daqing
Zip:
163316
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Dejun Yun
Phone:
13304690977
Facility:
Name:
The First Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150007
Country:
China
Status:
Recruiting
Contact:
Last name:
Yingyu Jin
Phone:
13796029276
Facility:
Name:
The Sixth Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150088
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Haiyan Gao
Phone:
15545545606
Facility:
Name:
Jixi Ji Mine Hospital
Address:
City:
Jixi
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jinyu Yang
Phone:
13763665650
Facility:
Name:
Qiqihar Hospital of Traditional Chinese Medicine
Address:
City:
Qiqihar
Zip:
161005
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenxiu Liu
Phone:
15904526839
Facility:
Name:
Luoyang Maternal and Child Health Hospital
Address:
City:
Luoyang
Zip:
471000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhanjun Zhang
Phone:
13939926329
Facility:
Name:
Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tao Jiang
Phone:
13837988831
Facility:
Name:
Shangqiu First People's Hospital
Address:
City:
Shangqiu
Zip:
476100
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weibing Yin
Phone:
13937057566
Facility:
Name:
Wuhan Mental Health Center
Address:
City:
Wuhan
Zip:
430012
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoliang Zhou
Phone:
18108650781
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xiangyang
Zip:
441021
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengjiang Cheng
Phone:
15207275328
Facility:
Name:
Nanzhang People's Hospital
Address:
City:
Xianyang
Zip:
441599
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xuesheng Li
Phone:
15871057798
Facility:
Name:
Zhuzhou Central Hospital
Address:
City:
Zhuzhou
Zip:
412007
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zuiming Jiang
Phone:
13873381276
Facility:
Name:
Affiliated Hospital of Inner Mongolia Minzu University
Address:
City:
Wuzhou
Zip:
028000
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoli Liu
Phone:
15247519335
Facility:
Name:
Wuxi No.2 People's Hospital
Address:
City:
Wuxi
Zip:
214002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongyu Huang
Phone:
13861740103
Facility:
Name:
Affiliated Hospital of Jinggangshan University
Address:
City:
Ji'an
Zip:
343000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Honghou Dai
Phone:
13807968267
Facility:
Name:
First Affiliated Hospital of Gannan Medical University
Address:
City:
Ganzhou
Zip:
341000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tianyu Zhong
Phone:
15279799667
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaozhong Wang
Phone:
13576041466
Facility:
Name:
Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan
Address:
City:
Changzhi
Zip:
046011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jufen Ma
Phone:
15935530258
Facility:
Name:
The Second Hospital of Shanxi Medical University
Address:
City:
Taiyuan
Zip:
030001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kunping Guan
Phone:
13700514558
Facility:
Name:
The Hospital of Shanxi University of Chinese Medicine
Address:
City:
Taiyuan
Zip:
030024
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanyuan Pan
Phone:
13934151016
Facility:
Name:
Xi'an People's Hospital (Xi'an Fourth Hospital)
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongli Liu
Facility:
Name:
The First Affiliated Hospital of Xi'an Medical University
Address:
City:
Xi'an
Zip:
710077
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhuo Li
Phone:
13363963035
Facility:
Name:
The General Hospital of Western Theater Command PLA
Address:
City:
Chengdu
Zip:
610083
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuan Liu
Phone:
15102813601
Facility:
Name:
Guang'an People's Hospital
Address:
City:
Guang'an
Zip:
638099
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuanjiu Xu
Phone:
15308287599
Facility:
Name:
The People's Hospital of Leshan
Address:
City:
Leshan
Zip:
614000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yin Xiang
Phone:
15608139066
Facility:
Name:
Tianjin Beichen Hospital
Address:
City:
Beichen
Zip:
300400
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kai Chen
Phone:
18630922553
Facility:
Name:
Tianjin Binhai New Area Dagang Hospital
Address:
City:
Binhai
Zip:
300270
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Heng Zhang
Phone:
13132181211
Facility:
Name:
Tianjing Medical University Cancer Institute & Hospital
Address:
City:
Hexi
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Ren
Phone:
18622221306
Facility:
Name:
The First People's Hospital of Kashgar Prefecture
Address:
City:
Kashgar
Zip:
844000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aimin Xu
Phone:
18909981658
Facility:
Name:
First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Zip:
650032
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Duan
Phone:
13808706308
Facility:
Name:
Qunjing Hospital of Traditional Chinese Medicine
Address:
City:
Qujing
Zip:
655000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fuxing Zhang
Phone:
13988901090
Facility:
Name:
Hwa Mei Hospital,University of Chinese Academy of Sciences
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yufeng Liao
Phone:
13566017561
Start date:
March 1, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Collaborator:
Agency:
National Natural Science Foundation of China
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05638269
